Mercy General Hospital First to Replace Heart Valve in Low-Risk Patients

Mercy General Hospital is the first in Northern California to Replace Heart Valve in Low-Risk Patient during Minimally Invasive Procedure

New Study enables broader patient population to be investigated for a minimally invasive and “recapturable” heart valve as an alternative to open-heart surgery.

Dignity Health Mercy General Hospital today announced it is the first hospital in Northern California to implant the CoreValve® Evolut® R System, a minimally invasive treatment for patients with failing aortic heart valves who are at a low surgical mortality risk.

Mercy General is one of 80 sites participating in a clinical study of the device used in a procedure called Transcatheter Aortic Valve Replacement (TAVR), a minimally invasive treatment option to open heart surgery. In a TAVR procedure, an artificial heart valve is mounted on a catheter, inserted via an artery in the leg and then guided through the arteries into the heart. Once in place, the device expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.

Mark Wheelis is the first patient enrolled in the clinical trial and the first in Northern California to receive the device as a low-risk patient. Wheelis was diagnosed with aortic stenosis but his symptoms were mild so doctors were watching him closely. In May, he met with Mercy General physicians to discuss his options, open heart surgery or a new clinical trial that would begin taking patients in a few months. “I was told that I was not eligible for TAVR, but there was a clinical trial that was starting soon so I decided to wait. My symptoms were not acute,” said Wheelis.

To date, the technology is commercially approved only for those patients with severe aortic stenosis who are at high or extreme risk for surgery. Michael Chang MD, cardiologist, Mercy General Hospital, is the lead investigator for the clinical trial. “The significance of this trial is that if TAVR has equal or better results than open heart surgical aortic valve replacement, then TAVR will be approved for this low risk population as well,” said Dr. Chang. “This will result in a new standard of care for patients with aortic stenosis. For isolated aortic stenosis, there will be very few patients that will undergo open heart surgery for aortic valve replacement.”

Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium build up. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. More than 100,000 people in the United States are diagnosed with severe aortic stenosis each year.

Wheelis, 72, a retired microbiology professor at UC Davis, feels like he’s back to normal. He hopes to eventually start his exercise routine six days a week. He is glad he decided to wait to take part in the low risk TAVR clinical trial. “I love the idea of contributing to the development of these kinds of procedures,” he said. “I would recommend it to others. It is so far superior than having your chest carved open and looks to me to be the future of valve replacement.”